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Kapp Surgical Instrument, Inc.

US

Last updated September 17, 2026

About

KAPP SURGICAL INSTRUMENT INC. Worldwide Sales and Manufacturing Services Learn how our custom instrument design service works. Learn more >> Instruments, implants, specialty sterile products. Shop our complete range of products, purchase bulk quantities for discounts

From the manufacturer's own website. Source

Information

Country
US
Address
4919 WARRENSVILLE CENTER RD., Bedford Heights, OH, 44128
LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1522875
DUNS Number
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Catalogue (126)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Seitz Solution Radial Head KCHI-2313
FDA UDI
Class IIActive
Seitz Solution Radial Head KCW-61
FDA UDI
Class IIActive
Seitz Solution Unlar Head KCUS-5265
FDA UDI
Class IIActive
Cosgrove Valve Retractor System KS-7101
FDA UDI
Class IActive
Seitz Solution Unlar Head KCS-62
FDA UDI
Class IIActive
Seitz Solution Radial Head KCHI-2616
FDA UDI
Class IIActive
PCL Retractor KS-9991
FDA UDI
Class IActive
Bulldog Clamp KS-3003
FDA UDI
Class IIActive
Seitz Solution Unlar Head KCUC-4865
FDA UDI
Class IIActive
Cosgrove Valve Retractor System KS-7101-UK
FDA UDI
Class IActive
Modified Javid Clamps KS-5002
FDA UDI
Class IIActive
Lateral Tibia Retractor - Right Right
FDA UDI
Class IActive
Vasectomy Instruments K-9555
FDA UDI
Class IActive
Seitz Solution Unlar Head KCUH-1617
FDA UDI
Class IIActive
Gripper K930607
FDA 510(k)
Class IIActive
Kapp Spinal Button K843368
FDA 510(k)
Class IIActive
Kapp Bari-Ring, Model Ks-Br-2005 K050384
FDA 510(k)
Class IIActive
Cosgrove Mitral Valve Retractor K844177
FDA 510(k)
Class IActive
Mondeal Contour Ho System K050657
FDA 510(k)
Class IIActive
Mondeal Radius Ho System, Model Ks-Mr-2005 K050655
FDA 510(k)
Class IIActive
Kapp Bari-Ring Endoscopic Marker, Model K-9536 K072216
FDA 510(k)
Class IIActive
Kapp Custom Ulnar Head Wrist Implant K033930
FDA 510(k)
Class IIActive
Ophthalmic Cannula K881487
FDA 510(k)
Class IActive
Kapp Custom Radial Head Elbow Implant K030237
FDA 510(k)
Class IIActive
Irrigation/Suction Probe K923667
FDA 510(k)
Class IActive
Michler-Kapp Cardiovascular Vent Catheter K200289
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
May 24, 2011Z-2753-2011—terminated

During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. Kapp Surgical decided to conduct the recall because we cannot be sure that incorrect instructions were not shipped.

Mar 5, 2008Z-0068-2012—terminated

A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. However, the shelf box containing the pouches is labeled correctly.